Medical device licence · 948 · Class 3
PROFIX TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 19, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 948
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 19, 1999
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PROFIX KNEE SYSTEM - METAPHYSEAL TIBIAL STEM
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “profix”. A notice may cover another product or only some lots: read it to see what it covers.
- PROFIX 750 Grams Mallet (2019-11-12)December 6, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.